QC Scientist II - Project Manager

When you’re part of the team at Thermo Fisher Scientific, you’ll do important work, like helping customers in finding cures for cancer, protecting the environment or making sure our food is safe. Your work will have impact, and you’ll be supported in achieving your career goals!Location/Division Specific InformationWe have industry leading sterile injectable facilities providing solutions to take essential product from Pre-Clinical to the market. Pharmaceutical products come in many different dose forms including inhalations, oral dose, cream/ointments and injectables.How will you make an impact?Coordinates new product introduction activities for the Microbiology department. Performs moderately complex analyses in a microbiology lab environment within defined procedures and practices. Supports internal development and/or manufacturing operations. Makes detailed observations and reviews, documents, and communicates test results; recommends solutions.What will you do?Serves as Microbiology Department representative on numerous project teams for new project introductions. Advises customers of compliant and efficient microbiological method validation and testing strategies.

Authors and reviews method validation reports, protocols, specifications and testing instructions. Has extensive interaction with customer document review and comment resolution. Writes SOPs and other instructional documents.

Conducts microbiological testing of in process products and finished products by internally developed and compendial test methods. Performs method development, suitability, and validation testing for Bioburden, Bacterial Endotoxins Testing, Sterility, and unique client specific studies.

Cleans and organizes work area, instrumentation, and testing materials. Maintains stock of commodities needed for testing support. Maintains and troubleshoots analytical instrumentation as needed.

Performs all duties in strict compliance with Standard Operating Procedures, Good Manufacturing Practices, Good Laboratory Practices, and Safety guidelines. Maintains compliance status required by company and facility standards. Recognizes and reports out-of-specification or unexpected results and non-routine analytical and product problems; recommends solutions.

How will you get here?EducationBachelor preferred - preferably with Biology or Chemistry concentration.

Associate degree required – preferably in Biotechnology or science concentration.

Equivalent combinations of education, training, and meaningful work experience may be considered if an Associate degree is acquired

ExperienceA minimum of 3 years of experience performing tests or analyses for pharmaceutical raw material, in process product, and finished product samples. Experience with common office software and data acquisition systems.

Experience with LIMS, SLIM, Trackwise, or Documentum a plus. Experience as a reviewer approver or qualified checker preferred.

Knowledge, Skills, AbilitiesProblem-solving skills and logical approach to solving scientific problems.

Good interpersonal and communication skills (both oral and written- legible handwriting).

Good presentation skills to present information to customers, clients, and other employees.

Strong Time Management Skills

Highly organized, meticulous and self-motivated

Good knowledge and understanding of microbiological methods and aseptic technique.

Good knowledge of quality and regulatory requirements in the pharmaceutical industry.

Ability to read, analyze, and interpret technical procedures and governmental regulations.

Ability to write procedures, protocols, and reports.

Ability to respond to common inquiries or complaints from customers or regulatory agencies.

Ability to apply mathematical operations, to such tasks as determination of test reliability, analysis of variance and correlation techniques.

Adaptable and Capable of working within a team as well as independently.

Knowledge of qualitative and quantitative microbiological Tests.

Think and act with a customer-centric mentality to deliver outstanding customer experiences.

Intellectually curious and embrace Practical Process Improvement (PPI).

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us (https://jobs.thermofisher.com/global/en/5-reasons-to-work-at-thermo-fisher-scientific) . As one team of 90,000 colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.Apply today! http://jobs.thermofisher.comThermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.Accessibility/Disability AccessJob Seekers with a Disability: Thermo Fisher Scientific offers accessibility service for job seekers requiring accommodations in the job application process. For example, this may include individuals requiring assistance because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or assisting a person with a disability, and require accessibility assistance or an accommodation to apply for one of our jobs, please submit a request by telephone at 1-855-471-2255. Please include your contact information and specific details about your required accommodation to support you during the job application process.This telephone line is reserved solely for job seekers with disabilities requiring accessibility assistance or an accommodation in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.